Dossiers

A.R.C. Pharma consultants conduct sound technical and regulatory evaluations, and have the expertise to write all types of authorisation dossiers, at all stages of the product life cycle. They also handle their submission, whatever the procedures, and ensure a timely and adequate follow-up.

Pharmacovigilance

Preparation of PSURs

Liaison with national and European authorities

A.R.C. Pharma ensures formatting and submission of all dossiers (marketing authorisation, pricing and reimbursement, advertising…), and if need be, can be mandated to follow-up your submission. We provide our services for all submission procedures for marketing authorisation: national, decentralised, mutual recognition (France and other member states), and centralised (EMA).